Application 219683

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INLEXZOGEMCITABINE HYDROCHLORIDESYSTEM;INTRAVESICALEQ 225MG BASEYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85742ORIG 2026-04-24
83317ORIG 2025-09-11
83315ORIG 2025-09-10